By Paul Goldberg
Lung cancer researcher Claudia Henschke accepted $3.6 million from the parent company of cigarette maker Liggett Group Ltd., The Cancer Letter has found.
The maker of Grand Prix, Pyramid, Liggett Select, Quest and Eve cigarettes provided the money in four installments between 2000 and 2003, and Henschke placed the funds in a non-profit group where she serves as president, tax documents show.
In her scientific articles, Henschke doesn’t disclose receiving money from Liggett. Instead, she declares support from the Foundation for Lung Cancer Early Detection, Prevention & Treatment, the non-profit that received the tobacco company money and which uses it to fund the work of the International Early Lung Cancer Action Program.
Though a press release was issued at the time the Liggett gift was announced, journal editors and cancer researchers haven’t been aware of the source of Henschke’s funding.
“Separate from the argument that one could say the end justifies the means, if you are using blood money, you need to tell people you are using blood money,” said Otis Brawley, chief medical officer of the American Cancer Society, one of the groups that helped fund I-ELCAP.
NCI Director John Niederhuber, too, was unaware of the source of Henschke’s funds. “The design of the research questions we ask and the interpretation of the results must be, to the best of our ability, above question,” Niederhuber said in an e-mail. “We cannot, and should not, hold ourselves to anything less, and we must always be transparent regarding any and all matters, real or perceived, which might call our scientific work into question.
“It is vital that, as scientists and clinicians, we maintain our bond of trust with our cancer patients, who so generously volunteer to participate in our clinical research. Any breach of that trust is not simply disappointing but, I believe, unacceptable.”
Henschke’s institution, Weill Cornell Medical College, has been aware of the tobacco money. Antonio Gotto, the dean of her medical school, is a member of the charity’s board of directors, as is Arthur Mahon, vice chairman of the institution’s board of overseers and its former chairman. David Yankelevitz, Henschke’s collaborator at Weill Cornell, is listed as the foundation’s secretary and treasurer. Another Weill Cornell colleague, oncologist Mark Pasmantier, is also on the board. Documents show that the charity has transferred $726,092 to Weill Cornell between 2000 and 2006, the last year for which the filings are publicly available.
Liggett officials acknowledge having given Henschke the money. “The company disclosed its gift at inception in a press release, contributed $3.6 million in over a three year period, and had no control or influence over the research,” Paul Caminiti, a spokesman for Vector Group, the owner of Liggett, said in an e-mail to The Cancer Letter.
The revelation that a tobacco company has been a major funder of Henschke’s research comes at the time when medical journals and providers and accreditors of continuing medical education are investigating her failure to disclose patents and royalties from commercial sponsors, including GE Healthcare. As the leading manufacturer of CT scanners, GE stands to benefit from Henschke’s campaign to screen asymptomatic former and current smokers (The Cancer Letter, Jan. 18). Several providers of continuing medical education are similarly investigating Henschke’s disclosures at CME events (The Cancer Letter, March 14, 2008).
Weill Cornell officials didn’t respond to questions from The Cancer Letter. However, in an interview with The New York Times, Gotto said the charity was set up by Henschke, Yankelevitz and another physician, and he joined the board sometime later.
“If we had been approached, we would not have set up the foundation,” Gotto said to the Times. “We would have accepted the gift directly. We think we behaved honorably. There was no attempt to set up a foundation to hide tobacco money.”
The Times and The Cancer Letter are publishing concurrent stories about this matter.
Liggett: CT Screening Can Save Lives
On Dec. 4, 2000, Vector Group Ltd., the parent company of Liggett Group Ltd., announced a donation of $2.4 million “to provide for the expansion of spiral CT scanning research at the Joan and Sanford I. Weill Medical College of Cornell University in New York City.
“The project is headed by Dr. Claudia Henschke of Weill Medical College, who has assembled an international, multi-site collaboration for lung cancer screening,” the press release states.
The press release quotes Bennett LeBow, chairman and CEO of Vector Group:
“We are very proud and thankful that we are able to help support this very important cause and believe it’s the right thing to do. Spiral CT scanning can potentially save millions of lives a year. We are especially pleased to partner with Weill Cornell Medical College and Dr. Henschke and her esteemed colleagues to further efforts to ensure the availability and reliability of this critical cancer screening method. We hope the other companies in the industry join us in our efforts.”
Henschke, too, gets a quote:
“Thanks to the contribution of Mr. LeBow and Vector Group, we have raised the initial funding needed to support this important research and data collection on the effectiveness of spiral CT scanning. In the U.S. alone, there are currently 48 million former smokers and 40 million smokers waiting to be screened by this method. This endowment brings us one step closer to amassing the data needed to ensure that this screening is reliable, affordable and accessible to all who need it going forward.”
The document is posted at http://www.tobacco. org/news/54637.html.
The Foundation for Lung Cancer Early Detection, Prevention & Treatment is not, technically, a foundation. In filings, it’s classified as a public charity. While foundations are set up primarily to distribute money, public charities are founded primarily to receive money and spend it on specific projects.
The group’s first tax form was dated Dec. 31, 2000, less than four weeks after the Liggett announcement. It received the Liggett money in four installments: $900,000 in 2000, another $900,000 in 2001, $1.2 million in 2002, and $600,000 in 2003.
Spending on Consultants
Tax documents show that over the years, payments to consultants have been the largest single line item in the foundation’s budget. Overall, consultants received $1,291,037 between 2000 and 2006.
In 2004 alone, consultants received $346,127, tax documents show.
Consultants aren’t customarily used by clinical trials cooperative groups. “In all my years as a group chair, the only time I can think of that we used consultants was to help us in the evaluation of our scientific programs, such as inviting outside experts to participate in our site visit preparations during a grant renewal or asking someone to participate in a scientific retreat to evaluate a particular research program or help us plan for the future,” said Richard Schilsky, chairman of Cancer and Leukemia Group B. “In such circumstances, we will reimburse travel expenses and might pay a modest honorarium, $500 to $1,000.”
Transfers of funds to Cornell were the second largest line item, and conferences were the third, adding up to $424,596.
Altogether, over the years the I-ELCAP sites received $390,000—less than a quarter of the funds that went to consultants. Most sites received $30,000 grants, tax documents show.
In 2004, Henschke started taking money from groups that specifically prohibit the practice of “commingling” of their funds with those received from tobacco companies.
Funds from these institutions were received by Weill Cornell for Henschke’s and I-ELCAP’s use and combined with the $1,057,086 surplus of Liggett money. The 2006 tax form shows that $243,228 remained in the foundation.
Over the past four years, Henschke received over $100,000 in grants and contracts from ACS, the society said. This included several $10,000 to $15,000 contributions for the annual meeting of the I-ELCAP, and a $61,850 contract to support the I-ELCAP pathology and cytology evaluation program.
Each time she accepted ACS funds, Henschke signed a document certifying that she didn’t represent a tobacco company or subcontract work to those who do.
The ACS definition of a “tobacco company” contained in each of these documents includes “any company that manufactures tobacco products and is commonly considered to be part of the tobacco industry, including subsidiaries and parent companies, as well as philanthropic foundations and other organizations closely linked with the tobacco industry.”
Grant and contract applications signed by Henschke and listing her as the principal investigator state that “in no event shall Dr. Claudia Henschke or any staff associated with the project or the funds hereinafter employ any entity or assign, subcontract, or delegate, directly or indirectly, any work to any entity under this agreement if such is a tobacco company.”
In 2004, the American Legacy Foundation, in conjunction with a British foundation, gave Weill Cornell and Henschke $1.8 million to conduct a 4,000-patient study designed to link CT screening with smoking-cessation programs.
As a condition for accepting funding from Legacy, institutions have to sign a statement pledging not to take funds from tobacco companies for the duration of the grant.
This clause in the grant conditions, known as Clause 12, states that “grants awarded under this program require that the dean or CEO of the school of public health confirm that the school of public health does not currently accept nor will accept any grant or anything else of value from any tobacco manufacturer, distributor, or other tobacco-related company during the grant period. This restriction is a policy of the American Legacy Foundation and applies to all of the foundation’s grantees and sub-grantees.”
Legacy spokesman Julia Cartwright said the foundation knew that Henschke had received money from a tobacco company in the past. However, the final transfer of funds from Liggett preceded the Legacy grant.
Though scientists who receive Legacy money are precluded from accepting concurrent funds from tobacco sources, surpluses of funds received from tobacco companies in the past are exempted from this prohibition, Cartwright said.
“The American Legacy Foundation requires grant recipients to agree not to accept tobacco funds or anything else of value from tobacco companies during the Legacy grant period,” she said in an e-mail. “It does not include a look-back provision, i.e., we do not disqualify grantees on the basis that they may have previously received tobacco support. If Legacy only supplied grants to entities that had never received tobacco dollars, unfortunately that list would be short and subsequently, our efforts to champion research and implement innovative programs to reduce tobacco use and save lives would have been seriously curtailed.
“Based on assurances from Weill Cornell that its Radiology Department would not accept funds (or anything else of value) from the tobacco industry during the period of our grant, we approved this grant because we believe that Dr. Henschke’s research holds promise in the effort to detect early lung cancer cases. Given the multi-site nature of this trial, her project is uniquely positioned to answer the fundamental question: ‘Does lung cancer screening adversely effect smoking cessation?’”
In 2006, the Foundation for Lung Cancer Early Detection, Prevention & Treatment made a $25,000 cash “gift” to Legacy, tax documents show.
Cartwright said the transfer was never made. “According to Legacy’s accounting records, we have received no check from either Weill Cornell or the Foundation for Lung Cancer Early Detection Prevention & Treatment in the amount of $25,000,” she said. “We made an inquiry to Weill Cornell about this $25,000 check and notified them that we had received no such check. They have re-examined their files and apparently this was an accounting error on their part.”
On March 10, at a gala at the Pierre hotel, Legacy gave Henschke its “Humanitarian in Medicine and Public Health Award.”
In 2007, the Flight Attendant Medical Research Institute gave $8.7 million to Weill Cornell to set up a “multidisciplinary research and clinical program to enhance early detection and treatment of diseases related to secondhand smoke exposure-including cancer, heart disease, emphysema, asthma, chronic bronchitis and osteoporosis.”
The initiative, called the FAMRI-I-ELCAP Collaborative Network, was expected to recruit 5,000 individuals from industries associated with exposure to secondhand smoke.
On its website, FAMRI states that it “does not support investigators who are currently receiving funds from the tobacco industry.” A FAMRI spokesman didn’t respond to a query from The Cancer Letter.
“I think all of them definitely should attempt to get the money back, if there is residual money that still remains,” said Robert Young, chancellor of the Fox Chase Cancer Center and chairman of the oversight committee of the National Lung Screening Trial, an NCI-sponsored randomized trial comparing CT with chest X-ray.
Liggett and the Cure
“One of the interesting questions to me is why did the tobacco companies decide to support her work?” said Jerome Kassirer, a professor at Tufts University and former editor of The New England Journal of Medicine. “That’s a fundamental question, and the answer has to be that they probably thought that her work would show that lung cancer is not as bad as it is thought to be. In fact, they are wrong. It is as bad.
“Her research is trying to show a cure rate of 90% or something of the sort, but the fact is that her evidence is too weak to show that,” Kassirer said.
The role of tobacco companies in funding Henschke’s research should have been disclosed in talks and publications, Kassirer said. “Of course, it should have been disclosed, because we would want to know what the nature of her research is getting at, and what we don’t know is what the connection might be between the funding and the results.”
Bruce Chabner, director of the Massachusetts General Hospital Cancer Center and editor of The Oncologist, a journal that published a paper by Henschke and Yankelevitz in its February issue said he, too, regards the latest conflict as relevant. “This only reinforces my concerns that full disclosure was not made,” said Chabner, whose editorial on Henschke’s disclosures appears in the March issue of the journal.
“This is a huge amount of money,” said Young. “This is what just amazes me. This is not $100,000, which would be big enough. But $3.6 million! It’s just difficult to imagine that that amount of money would not influence the researcher’s behavior.”
Merrill Goozner, director of the Integrity in Science Project of the Center for Science in the Public Interest, said Henschke’s foundation is a smoke screen hiding the support of tobacco companies.
“When a researcher take money from organizations funded by industry, it’s the same as taking money from the industry itself,” Goozner said. “I didn’t know Liggett as the prevention of lung cancer. I though they were the cause of lung cancer. A discerning reader might want to look at the data a bit more closely if he is informed that the research is funded by a tobacco company.”
Henschke has published 70 papers since establishing the charity to receive tobacco money. Disclosures in most of these papers state that she had no relevant conflicts. Several journals are investigating whether the technologies embedded in the I-ELCAP protocol should have been disclosed.
JAMA: Conflicts Are Relevant
The Journal of the American Medical Association and the ACS journals Cancer and Cytopathology are about to publish items listing Henschke’s business interests.
The March 24 issue of JAMA published Henschke’s and Yankelevitz’s letter to the editor disclosing their potential conflicts.
“We believe that none of the patent applications or the license agreement played any role in the design of the study, interpretation of the data, or drafting of the publications in JAMA and therefore did not disclose them,” Henschke and Yankelevitz wrote. “However, we recognize that JAMA policy requires disclosure of any potential conflicts of interest, and in retrospect we regret that we did not disclose these financial relationships...We apologize for any misperceptions that may have resulted.”
Responding to the letter, JAMA Editor in Chief Catherine DeAngelis wrote that the conflicts are relevant.
“The disclosures included in the letter by Drs. Henschke and Yankelevitz would have been published with their JAMA article and letter if they had been disclosed at that time,” DeAngelis wrote. “The editors believe that they are relevant to these publications.”
DeAngelis said the journal wasn’t aware of Henschke’s and Yankelevitz’s tobacco ties. “I would never publish a paper dealing with lung cancer from a person who had taken money from a tobacco company,” she said to The New York Times.
The ACS journals are publishing a publisher’s note listing Henschke’s and Yankelevitz’s patents, licenses and funding sources. “Journal policy is that all authors sign an Authorship Responsibility, Financial Disclosure, and Copyright Transfer form, which states ‘any direct financial interest in the subject matter discussed should be disclosed,’” the note states. “Full disclosure of the interests detailed above would have allowed the peer reviewers to consider the study in light of the authors’ interests and whether this study’s authors would benefit financially from its conclusions. If these interests had been disclosed, it would not have necessarily prevented publication of the papers, but these interests would have been published with the papers.”
The New England Journal of Medicine said it had been given full disclosure in connection with the publication of the I-ELCAP paper on Oct. 26, 2006. However, it is unclear whether disclosure would have been acceptable for granting of Continuing Medical Education Credits (The Cancer Letter, March 14, 2008).
“I can’t understand the New England Journal’s position,” Young said. “To say that these weren’t conflict, to kiss it off, is really shocking.”
An NEJM spokesman said the journal would look into the funding matter. “We have recently become aware of the source of the funding, which was not disclosed by the authors at the time of publication, and are reviewing the matter,” Karen Pedersen, a spokesman for the journal, said in an e-mail.
The relationship between I-ELCAP and Liggett presents a novel problem in the context of CME, said Murray Kopelow, chief executive of the Accreditation Council for Continuing Medical Education.
“The funding of CME by the tobacco industry is a CME issue,” Kopelow said in an e-mail. “ACCME has never before been made aware of CME being funded by the tobacco industry. Technically this industry is not included in what ACCME defines as a ‘commercial interest,’ so ACCME’s disclosure and independence policies do not apply. We are going to recommend to ACCME that ACCME open discussions on this issue to see if policy needs to be modified.”
CME conflict of interest rules are written to prevent health care companies from influencing the content of education. “We’ve never seen a scenario where a tobacco company is involved in CME,” said Kopelow, who plans to present this matter to the ACCME board at its next meeting.
Liggett, the smallest of the major U.S. tobacco companies, has pursued the strategy of cooperation with prosecutors and plaintiffs attorneys. The company has sought to settle legal claims and turn over privileged documents. In return, it has been able to avoid being prosecuted or being named in class action lawsuits.
CT screening figures in several aggregated civil lawsuits, where plaintiffs demand regular scans as part of “medical monitoring” of former and current smokers, and at least four I-ELCAP investigators have appeared as expert witnesses for the plaintiffs. Liggett hasn’t been named in any of these suits.
No major medical society recommends CT screening, and FDA has approved the device only for diagnostic purposes. Two NLST investigators agreed to testify for the defense in those cases, arguing that the benefits of CT screening for lung cancer haven’t been demonstrated.
At the behest of the Lung Cancer Alliance, a pro- screening group that works closely with Henschke, the House Committee on Oversight and Investigations last October started a probe of alleged conflicts of interest on the part of NLST investigators (The Cancer Letter, Oct. 26, 2007).
“I find it ironic that this type of attacks could be levied at people doing a well-designed and responsible trial by groups that have not done such a trial and were receiving huge amounts of money from the tobacco industry,” Young said. “That’s just appalling.”
The status of the House investigation is uncertain.
While proponents of screening have characterized NLST as unethical and outmoded, NCI is committed to complete it.
“It is important, as well, to remember that no single study can answer every question about a broad area of research,” Niederhuber said in an e-mail. “It is often said that good research not only provides new knowledge but also more questions. The NCI is committed to seeing its National Lung Screening Trial through to completion, to help answer many of the questions surrounding mortality benefit of screening for lung cancer. Clinical trials that significantly advance knowledge often take longer than any of us would hope, but we must allow the research to go forward. The public health necessitates that clinical practice be driven by scientific evidence. We owe this to the public and to those who generously agreed to participate.”